TREATMENT CATHETER SYSTEM

• US 20150238314A1
• Filed: 09/12/2012
• Published: 08/27/2015
• Est. Priority Date: 09/12/2011
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Brtlein, Georg, Nasr, Malek
• Granted Patent: US 9,895,224 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A treatment catheter system for treatment of a heart valve includes a circumferential valve tissue structure and an elongate catheter member, and and has an inner lumen, proximal and distal end portions. The system includes a catching component which can be positioned at the distal end portion of the catheter member to be non-separable from the catheter member. An outer member extends circumferentially around the catheter member. The circumferential valve tissue structure is correspondingly arranged between the catheter member and the outer member. A catching mechanism reduces a radial distance between the catheter member and the outer member to catch the valve tissue between the outer member and the catheter member via a catching opening to immobilize and treat the caught valve tissue on the distal end portion of the catheter member.

Claims

1. A treatment catheter system for treatment of a bloodstream valve having a circumferential valve tissue structure, comprising

an elongate catheter member to be disposed at the interior of the circumferential valve tissue structure and to be removed therefrom after treatment, wherein the elongate catheter member extends along a longitudinal axis and has an inner lumen and proximal and distal end portions, and wherein

the elongate catheter member comprises a catching component which is or can be positioned at the distal end portion of the elongate catheter member so as to be non-separable from the elongate catheter member at least when being positioned at the distal end portion of the elongate catheter member and which at least when being positioned at the distal end portion of the elongate catheter member comprises a lateral groove which extends transverse to the longitudinal axis and which opens to a lateral outer side so as to form a lateral catching opening, an elongate flexible outer member to be disposed at the exterior of the valve structure at a level of the lateral groove, wherein

the elongate flexible outer member can at least partially extend circumferentially around the catheter member with valve tissue of the circumferential valve tissue structure being correspondingly circumferentially arranged between the elongate catheter member and the elongate flexible outer member, and

a catching mechanism operable to reduce a radial distance between the elongate catheter member and the elongate flexible outer member so as to catch at least part of the valve tissue between the outer member and the elongate catheter member within the lateral groove via the catching opening to thereby immobilize the caught valve tissue on the distal end portion of the elongate catheter member.

2. The treatment catheter system according to claim 1, wherein the catching component is moveable relative to the elongate catheter member and can be forwarded and retracted or otherwise exposed via the inner lumen of the elongate catheter member.

3. The treatment catheter system according to claim 1, wherein the catching component is integrally formed with the elongate catheter member at the distal end portion of the elongate catheter member.

4. The treatment catheter system according to claim 1, wherein the catching component is formed by a cage and wherein the lateral groove is provided as a circumferential groove formed in the outer circumferential surface of the cage.

5. The treatment catheter system according to claim 4, wherein the cage is provided to be radially compressible and expandable so that it can be accommodated within the inner lumen of the elongate catheter member in a radially compressed condition and can be expanded or self-expands at the distal end portion of the elongate catheter member.

6. The treatment catheter system according to claim 4, wherein the cage is formed by a plurality of elongate wires substantially extending along the longitudinal axis of the elongate catheter member and being angularly spaced around the longitudinal axis of the elongate catheter member, the elongate wires each comprises a radially and inwardly bended bending portion, the bending portions forming the lateral groove.

7. The treatment catheter system according to claim 6, wherein each wire is provided in and moveable relative to a sheath which is provided in the lumen of the elongate catheter member and moveable relative to the elongate catheter member.

8. The treatment catheter system according to claim 5, wherein the wires are connected to each other by a substantially non-compressible front body having a rounded outer side and having an outer diameter slightly larger than an inner cross-sectional diameter of the lumen of the elongate catheter member to be able to provide a plug for closing a frontal end opening of the inner lumen of the elongate catheter member.

9. The treatment catheter system according to claim 1, wherein the catching component is formed by a tubular sleeve having a lateral cutout extending in a transverse direction of the longitudinal axis of the elongate catheter member and forming the lateral groove.

10. The treatment catheter system according to claim 1, wherein the catching component comprises a blunt front part.

11. The treatment catheter system according to claim 1, further comprising an elongate flexible perforation component which can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and which is operable such as to provide a perforation through the valve tissue caught in the lateral groove or through valve tissue adjacent to the caught valve tissue.

12. The treatment catheter system according to claim 11, wherein the perforation component is formed by a needle which is provided and arranged such as to be forwarded into the lateral groove.

13. The treatment catheter system according to claim 1, further comprising an anchor component which can be forwarded through the inner lumen of the elongate catheter member and can be placed within the caught valve tissue or within adjacent valve tissue.

14. The treatment catheter system according to claim 13, further comprising a chord attached to the anchor component.

15. The treatment catheter system according to claim 11, further comprising an anchor component which can be forwarded through the inner lumen of the elongate catheter member and can be placed within the caught valve tissue or within adjacent valve tissue, wherein

the perforation component is hollow, and

wherein the anchor component is provided such that it can be forwarded through the perforation component to the distal end portion of the elongate catheter member.

16. The treatment catheter system according to claim 1, further comprising a medical drug supplying component which is provided such that it can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and such that it can forward a medical drug to the caught valve tissue or the adjacent valve tissue,

17. The treatment catheter system according to claim 16, further comprising an elongate flexible perforation component which can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and which is operable such as to provide a perforation through the valve tissue caught in the lateral groove or through valve tissue adjacent to the caught valve tissue, wherein

the perforation component is hollow, and wherein

the medical drag supplying component is provided such that it can be forwarded to the distal end portion of the elongate catheter member through the perforation component.

18. The treatment catheter system according to claim 1, further comprising marker members fixedly attached on the catheter member and the elongate flexible outer member, wherein

the marker members are made from a material different than the material of the elongate catheter member and outer member respectively, to allow identifying relative positions and orientations of the elongate catheter member and the elongate flexible outer member using material-sensitive imaging techniques.

19. The treatment catheter system according to claim 1, wherein

the catching component and the elongate flexible outer member each comprise an electrode which is electrically connected to an electric energy source, and wherein

the electrodes of the catching component and the elongate flexible outer member selectively produce an electric field between each other using electric energy supplied from the energy source to open holes in cell membranes of the valve tissue.

20. The treatment catheter system according to claim 1, wherein the catching component is provided with an artificial heart halve.

21. The treatment catheter system according to claim 1, wherein

the elongate flexible outer member is provided with a prosthesis having an inner lumen that at least partially receives the elongate flexible outer member to be slideable along a longitudinal direction of the elongate flexible outer member, and wherein

the prosthesis is configured to be fixated to the bloodstream valve.

22. The treatment catheter system according to claim 21, wherein

the prosthesis has an outer cross-sectional diameter that is defined in a radial direction of a longitudinal axis of the prosthesis, that is smaller than a width of the lateral groove in a direction of the longitudinal axis of the elongate catheter member.

23. A method for surgical treatment of a bloodstream valve having a circumferential valve tissue structure, the method comprising:

advancing the treatment catheter system according to claim 1 into a vicinity of the bloodstream valve;

placing the lateral groove of the catheter member in an interior of the circumferential valve tissue structure;

placing the elongate outer member at least partially around an outside of the circumferential tissue structure at an axial level, with respect to the longitudinal axis, of the lateral groove;

reducing a distance between the elongate outer member and the lateral groove so as to at least partially force tissue of the circumferential valve tissue structure into the lateral groove; and

removing the catheter member and the elongate outer member from the patient.

24. A method for surgical treatment of a bloodstream valve comprising a circumferential valve tissue structure of a patient using a treatment catheter system comprising a catheter member having a longitudinal axis and a lateral groove, and an elongate outer member, the method comprising

placing the lateral groove of the catheter member in an interior of the circumferential valve tissue structure,

placing the elongate outer member at least partially around an outside of the circumferential tissue structure at an axial level, with respect to the longitudinal axis, of the lateral groove,

reducing a distance between the elongate outer member and the lateral groove so as to at least partially force tissue of the circumferential valve tissue structure into the lateral groove, and

removing the catheter member and the elongate outer member from the patient.

25. The method according to claim 24, wherein

the blood stream valve is a mitral valve connecting a ventricular chamber with an atrial chamber and having a valve annulus and the circumferential valve tissue structure on a side of the ventricular chamber, and wherein

placing the lateral groove comprises placing the lateral groove in the ventricular chamber close to the annulus.

26. The method according to claim 25, wherein

the ventricular chamber and the atrial chamber define an axial direction therebetween, wherein

the treatment catheter system further comprises a prosthesis having an inner lumen at least partially receiving the elongate outer member, and wherein

reducing the distance comprises forcing at least a part of the prosthesis into the lateral groove, and wherein

the method further comprises moving the lateral groove in an axial direction of the valve towards the annulus so that the prosthesis is in close contact with the annulus, and

fixing the prosthesis to the annulus.